BTL-995-rTMS

Transcranial Magnetic Stimulator

BTL Industries Inc.

The following data is part of a premarket notification filed by Btl Industries Inc. with the FDA for Btl-995-rtms.

Pre-market Notification Details

Device IDK212723
510k NumberK212723
Device Name:BTL-995-rTMS
ClassificationTranscranial Magnetic Stimulator
Applicant BTL Industries Inc. 362 Elm Street Marlborough,  MA  01752
ContactDavid Chmel
CorrespondentDavid Chmel
BTL Industries Inc. 362 Elm Street Marlborough,  MA  01752
Product CodeOBP  
CFR Regulation Number882.5805 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-27
Decision Date2022-03-04

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